LEVOFLOXACINA 5 mg /Ml Infusion Solution

Зміст інструкції

1. LEVOFLOXACINA GALENICA SENESE 5mg/ml solution for infusion
   1. What Levofloxacina Galenica Senese infusion solution is and what it is used for.
   2. What you need to know before using Levofloxacina Galenica Senese infusion solution
   3. How to use Levofloxacina Galenica Senese
   4. Possible side effects
   5. How to store Levofloxacina Galenica Senese
   6. Contents of the pack and other information

LEVOFLOXACINA GALENICA SENESE 5mg/ml solution for infusion

levofloxacin

Generic medicine
Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful. If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Levofloxacina Galenica Senese is and what it is used for.
• 2. What you need to know before you use Levofloxacina Galenica Senese
• 3. How to use Levofloxacina Galenica Senese.
• 4. Possible side effects.
• 5. How to store Levofloxacina Galenica Senese
• 6. Contents of the pack and other information.

1. What Levofloxacina Galenica Senese infusion solution is and what it is used for.

The name of this medicine is Levofloxacina Galenica Senese.
Levofloxacina Galenica Senese contains a medicine called levofloxacin. This medicine
belongs to a group of medicines called antibiotics. Levofloxacin is a quinolone antibiotic.
This medicine works by killing the bacteria that cause infections in the body.
Levofloxacina Galenica Senese can be used for the treatment of infections:

• of the lungs, in patients with pneumonia
• of the urinary tract, including kidneys and bladder,
• of the prostate, where an infection may develop that is persistent
• of the skin and subcutaneous tissue, including muscles. These are sometimes called “soft tissues”.

2. What you need to know before using Levofloxacina Galenica Senese infusion solution

Do not use this medicine and tell your doctor if:

• You are allergic (hypersensitive) to levofloxacin, to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin, or ofloxacin, or to any of the excipients of Levofloxacina Galenica Senese infusion solution (listed in section 6). The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat and tongue.
• You have had epilepsy
• You have had problems with your tendons, such as tendinitis, related to treatment with a quinolone antibiotic. Tendons are fibrous structures that connect muscles to the skeleton.
• You are a child or adolescent during the growth period (up to 18 years).
• You are pregnant, may become pregnant or think you may be pregnant.
• You are breastfeeding.

Do not take this medicine if the above applies to you in any way. If you have any
doubts, ask your doctor, nurse or pharmacist before taking Levofloxacina
Galenica Senese.

Before taking this medicine
Do not take antibacterial medicines based on quinolones/fluoroquinolones, including
Levofloxacina Galenica Senese, if you have previously had any serious adverse reaction during
treatment with a quinolone or fluoroquinolone. In this case, inform your doctor as soon as possible.

Contact your doctor, nurse or pharmacist before taking this medicine, if:
you are 60 years old or older
you are taking corticosteroids, sometimes called steroids (see “Other medicines and
Levofloxacina Galenica Senese”)
You have undergone a transplant
You have had seizures
You have suffered brain damage following a stroke or other brain damage, as this may
increase the risk of seizures
you suffer from kidney problems
you suffer from a disease known as “glucose-6-phosphate dehydrogenase
(G6PD) deficiency” or a family member is affected. Administration of this
medicine makes the development of blood problems more likely.

• a psychiatric illness is present in your medical history. You may develop suicidal thoughts and may self-harm have heart problems - particular attention must be paid when using this type of medicine, if you were born with or have a family history of prolonged QT interval (displayed on an ECG, an electrical recording of the heart), if you have an imbalance of salts in the blood (especially a low level of potassium or magnesium in the blood), have a very slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an elderly patient or if you are taking other medicines that can cause abnormal changes in the ECG (see paragraph “Other medicines and Levofloxacina Galenica Senese”)
• you suffer from blood pressure problems
• you suffer from diabetes - you may need to carefully monitor your blood sugar levels
• you suffer from myasthenia gravis
• you have nerve problems (peripheral neuropathy)
• you experience severe, persistent and/or bloody diarrhea during or after treatment as this may be a sign of a serious inflammation of the intestine (pseudomembranous colitis) which may occur after treatment with antibiotics
• you are exposed to strong sunlight or artificial ultraviolet (UV) rays (e.g. sunbeds, solariums) you may be subject to sunburn-like reactions due to increased photosensitivity. Stay away from direct sunlight. Make sure to use high-protection sun creams, wear a hat and clothing that covers your arms and legs and avoid sunbeds
• you have or have had liver problems
• your vision should decrease or if your eyes should otherwise be compromised, consult an ophthalmologist immediately
• you have been diagnosed with an enlargement or “enlargement” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel).
• you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta).
• you have a family history of aortic aneurysm, aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue diseases such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, high blood pressure or known atherosclerosis).

Contact your doctor, nurse or pharmacist when you are taking fluoroquinolones if:

• you experience sudden abdominal, chest or back pain, go to the emergency room immediately.

When taking this medicine
Rarely, pain and swelling in the joints and inflammation or rupture of the
tendons can occur. The risk is higher if you are elderly (over 60 years of age), if you have received an organ
transplant, if you have kidney problems or if you are being treated with corticosteroids. Inflammation and
rupture of tendons can occur within the first 48 hours of treatment and up to several months after
the end of therapy with Levofloxacina Galenica Senese. At the first signs of pain or inflammation
in a tendon (for example in the ankle, wrist, elbow, shoulder or knee), stop the
treatment with Levofloxacina Galenica Senese, consult your doctor and keep the painful part at
rest. Avoid any unnecessary movement, as the risk of tendon rupture may
increase.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning,
tingling, numbness and/or weakness, especially in the feet and legs or hands and
arms, can occur. In this case, stop treatment with Levofloxacina Galenica Senese and inform
your doctor immediately, to prevent nerve damage from becoming permanent.

Serious, prolonged, disabling and potentially irreversible side effects
Antibacterial medicines based on fluoroquinolones/quinolones, including Levofloxacina Galenica Senese,
have been associated with very rare but serious side effects, some of which are prolonged (lasting
months or years), disabling or potentially irreversible. These include pain in the tendons, muscles and
joints of arms and legs, difficulty walking, abnormal sensations such as
tingling, tingling, itching, numbness or burning (paresthesia), disorders of the senses
such as altered vision, taste, smell and hearing, depression, impaired
memory, severe fatigue and severe sleep disturbances.
If you experience any of these side effects after taking Levofloxacina Galenica
Senese, contact your doctor immediately before continuing treatment. The doctor will decide
together with you whether to continue treatment and will also consider the use of an antibiotic
from another class.
If you have any doubts that the above may apply to you in any way, contact your doctor or
pharmacist before taking Levofloxacina Galenica Senese.
If your doctor suspects that you may be infected by organisms MRSA
(Staphylococcus aureus – methicillin-resistant) you will be treated with a different antibiotic.
If you have any doubts that the above may apply to you in any way, contact your doctor,
nurse or pharmacist before taking Levofloxacina Galenica Senese.

Other medicines and Levofloxacina Galenica Senese
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including over-the-counter medicines, including herbal medicines. This is because Levofloxacina
Galenica Senese can affect the mechanism of action of other medicines. Some medicines
can also affect the mechanism of action of Levofloxacina Galenica Senese

In particular, tell your doctor if you are taking any of the following medicines. This
because the concomitant administration of Levofloxacina Galenica Senese may increase the
possibility that you experience side effects:

• Corticosteroids, sometimes called steroids - used to treat inflammation. The possibility that you develop inflammation and/or tendon rupture is greater.
• Warfarin - used to thin the blood. The possibility that you experience bleeding is greater. Your doctor may ask you to have regular blood tests to check your blood clotting.
• Theophylline - used for breathing problems. The possibility that you experience a seizure is greater if you take theophylline in combination with Levofloxacina Galenica Senese.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indometacin. The possibility that you experience a seizure if taken in combination with Levofloxacina Galenica Senese is greater.
• Cyclosporine - used for organ transplants. The possibility that you experience the typical side effects of cyclosporine is greater.
• Medicines known for their effects on the heartbeat. These include medicines that can alter the heart rhythm: medicines that belong to the class of antiarrhythmics (for example quinidine, hydroquinidine, amiodarone, sotalol, dofetilide, ibutilide), drugs for depression (tricyclic antidepressants such as amitriptyline and imipramine), some drugs for bacterial infections (antibiotics that belong to the class of macrolides such as erythromycin, azithromycin and clarithromycin).
• Probenecid - used to treat gout.
• Cimetidine used for ulcers and heartburn. If you have kidney problems, your doctor may prescribe you a lower dose. Contact your doctor if the above applies to you in any way.

Urine test for opioids
In patients taking Levofloxacina Galenica Senese, urine tests may give “false-positive” results for strong painkillers called “opioids”. If your doctor deems it necessary to have urine tests done, inform them that you are taking Levofloxacina Galenica Senese.

Tuberculosis test
This medicine can cause “false negative” results in some laboratory tests that look for
bacteria that cause tuberculosis.

Pregnancy and breastfeeding
Do not take this medicine if:

• you are pregnant, may become pregnant or think you may be pregnant
• you are breastfeeding or plan to breastfeed

Ask your doctor or pharmacist for advice before taking any medicine if you are
pregnant or breastfeeding.

Driving and using machines
Side effects can occur after taking this medicine and these include
dizziness, drowsiness, a subjective feeling of movement (vertigo) or visual disturbances. Some of these
side effects can alter your ability to concentrate and your reaction speed. If this
happens, do not drive vehicles or perform activities that require a high level of attention.

Levofloxacina Galenica Senese infusion solution contains sodium
This medicine contains 354.2 mg of sodium per each 5 mg/ml – 100 ml infusion bag.
This is equivalent to 17.7% of the recommended daily intake with the diet of an
adult

3. How to use Levofloxacina Galenica Senese

How Levofloxacina Galenica Senese is administered:

• Levofloxacina Galenica Senese solution for infusion is a medicine reserved for hospital use.
• The medicine will be administered to you by the doctor or nurse via injection. The injection will be given into one of your veins and will last for a certain period of time (this procedure is called intravenous infusion).
• Levofloxacina Galenica Senese solution for infusion the infusion time must be 60 minutes or longer.
• Heart rate and blood pressure must be monitored constantly. This is because an abnormal increase in heart rate and a temporary drop in blood pressure are possible side effects that have been observed during the infusion of a similar antibiotic. If your blood pressure should drop significantly while you are receiving the infusion, it will be stopped immediately.

How much Levofloxacina Galenica Senese solution for infusion is administered
If you have doubts about why you are being administered Levofloxacina Galenica Senese or if you want more
information about the amount of Levofloxacina Galenica Senese that has been administered to you, please contact
your doctor, nurse or pharmacist.

• The doctor will decide how much Levofloxacina Galenica Senese needs to be administered.
• The dose will depend on the type of infection you have contracted and the location of the infection in the body
• The duration of treatment will depend on the severity of the infection

Adults and the elderly

• Pneumonia: 500 mg once or twice a day
• Urinary tract, including kidneys or bladder: 250 mg once a day (the dose may be increased in cases of severe infections) Prostate: 500 mg once a day
• Skin and subcutaneous tissue, including muscles: 500 mg twice a day.

Adults with kidney problems
The doctor may need to reduce the dose.

Use in children and adolescents
This medicine should not be administered to children or adolescents.

Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine. This is because
the skin will become much more sensitive to the sun and can burn, itch or serious lesions may occur,
if you do not observe the following precautions:

• Make sure to use a sunscreen with a high protection factor
• Always wear a hat and clothing that covers your arms and legs
• Avoid sunbeds

If you receive more Levofloxacina Galenica Senese than you should
It is unlikely that you will be injected with an excessive amount of this medicine by the doctor or
nurse. The doctor and nurse will monitor your progress and ensure the dose
to be administered to you. If you have any doubts, always ask why you are being administered a dose
of the medicine.
Receiving an excessive amount of Levofloxacina Galenica Senese solution for infusion can
cause the following effects to occur: seizures (excessive epilepsy), confusion, dizziness, feeling of fainting and heart problems that can lead to irregular heartbeats and feeling unwell (nausea).

If you miss a dose of Levofloxacina Galenica Senese
The doctor or nurse will receive instructions on how much of the medicine to administer to you. It is
unlikely that this medicine will not be administered to you as prescribed. However,
if you believe you have missed a dose, inform your doctor or nurse.

If you stop the treatment with Levofloxacina Galenica Senese
The doctor or nurse will continue to administer Levofloxacina Galenica Senese solution for infusion
to you even if you feel better. If the administration is stopped too
early, your condition may worsen or bacteria may develop resistance to
the medicine. After a few days of treatment with the infusion solution, the doctor may decide
to change the route of administration of this medicine to the pharmaceutical form in
tablets to complete the course of treatment.
If you have any doubts about the use of this medicine, please contact your doctor, nurse or
pharmacist.

4. Possible side effects

Like all medicines, Levofloxacina Galenica Senese can cause side effects, although not everyone gets them.
Usually, these effects are mild or moderate and often disappear after a short time.

Very rare(may affect up to 1 in 10,000 people)

• you have an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue

Stop taking Levofloxacina Galenica Senese solution for infusion and immediately tell your
doctor or nurse if you notice any of the following serious side effects– you may need to
receive urgent medical treatment: Rare(may affect up to 1 in 1,000 people)

• watery diarrhoea with possible blood, sometimes accompanied by stomach cramps and high fever. This may indicate a serious intestinal problem
• pain and inflammation of tendons or ligaments which may, in some cases, rupture. The Achilles tendon is most commonly affected.
• convulsions

Very rare(may affect up to 1 in 10,000 people)

• burning, tingling, pain or numbness. These signs may indicate a condition called “neuropathy”

Not known (the frequency cannot be estimated from the available data)

• severe skin rash that may include blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals
• loss of appetite, yellowing of the skin and eyes, dark urine, itching or stomach pain. These may be signs of liver problems which can include fatal liver failure (liver failure that can cause death).

If your vision becomes blurred or if you experience any eye discomfort while taking
Levofloxacina Galenica Senese, consult an ophthalmologist immediately.

Tell your doctor if any of the following side effects worsen or last for more than a few
days:Common:(may affect up to 1 in 10 people)

• problems sleeping
• headache, dizziness
• feeling unwell (nausea, vomiting) and diarrhoea
• increased levels of liver enzymes in the blood
• reactions at the infusion site
• inflammation of a vein

Uncommon(may affect up to 1 in 100 people)

• changes in the number of other bacteria or fungi, fungal infection called Candida, which may require treatment
• changes in the number of white blood cells shown in some blood tests (leukopenia, eosinophilia)
• feeling stressed (anxiety), feeling confused, feeling nervous, drowsiness, tremor, vertigo
• shortness of breath (dyspnea)
• change in the taste of things, loss of appetite (anorexia), stomach upset or indigestion (dyspepsia), pain in the stomach area, feeling bloated (flatulence), constipation
• itching and rash, severe itching or hives, excessive sweating (hyperhidrosis)
• joint or muscle pain
• blood tests may show abnormal results due to liver (increased bilirubin) or kidney (increased creatinine) problems
• general weakness

Rare(may affect up to 1 in 1,000 people)

• bruising and easy bleeding due to a decrease in the number of platelets in the blood (thrombocytopenia)
• low number of white blood cells (neutropenia)
• exaggerated immune response (hypersensitivity)
• low blood sugar levels (hypoglycemia). This is important for those who suffer from diabetes
• seeing or hearing things that do not exist (hallucinations, paranoia), changes in beliefs and thoughts (psychotic reactions) with the possibility of developing suicidal thoughts or acts
• feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares
• feeling of tingling in the hands and feet (paresthesia)
• hearing problems (tinnitus) or vision problems (blurred vision)
• unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
• muscle weakness. This is important for patients who suffer from myasthenia gravis (a rare nervous system disease)
• changes in kidney function and occasional kidney failure which may be caused by an allergic reaction to the kidneys called interstitial nephritis
• fever

Not known (the frequency cannot be estimated from the available data)

• decrease in red blood cells (anemia). This can lead to paleness or yellowish skin due to damage to red blood cells and a decrease in the number of all types of blood cells (pancytopenia)
• The bone marrow stops producing new blood cells, which can cause fatigue, decreased ability to fight infections and uncontrolled bleeding (bone marrow failure)
• fever, sore throat and a general feeling of being unwell that does not go away. This may be due to a decrease in the number of white blood cells in the blood (agranulocytosis)
• lack of blood flow (anaphylactic shock)
• increased blood sugar levels (hyperglycemia) or decreased blood sugar levels leading to coma (hypoglycemic coma). This is important for those who suffer from diabetes.
• change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling very excited, euphoric, agitated or enthusiastic (mania)
• difficulty moving and walking (dyskinesia, extrapyramidal disorders)
• temporary loss of consciousness or posture (syncope)
• temporary loss of vision, eye inflammation
• worsening or loss of hearing
• unusually fast heartbeat, irregular heartbeat with life-threatening including cardiac arrest, changes in the heartbeat (called “prolongation of the QT interval” seen on the electrocardiogram, heart electrical activity)
• difficulty breathing or wheezing (bronchospasm)
• allergic reactions in the lungs
• pancreatitis
• inflammation of the liver (hepatitis)
• increased sensitivity of the skin to the sun or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation)
• inflammation of the blood vessels throughout the body due to an allergic reaction (vasculitis)
• inflammation of the internal tissues of the mouth (stomatitis)
• breakdown and destruction of muscles (rhabdomyolysis)
• redness and swelling of the joints (arthritis)
• pain, including back pain, chest pain and limb pain
• Sudden involuntary jerks, fasciculations or contractions (myoclonus)
• attacks of porphyria in patients who already suffer from porphyria (a very rare metabolic disease)
• persistent headache with or without blurred vision (benign intracranial hypertension)

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as inflammation of the tendons, tendon rupture, joint pain, arm or leg pain, difficulty walking, abnormal sensations such as tingling, prickling, itching, burning, numbness or pain (neuropathy), fatigue, impaired memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation) changes in hearing, vision, taste and smell, have been associated with the use of antibiotics of the quinolone and fluoroquinolone type, in some cases regardless of pre-existing risk factors.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levofloxacina Galenica Senese

Keep the medicine out of sight and reach of children.
Keep the vial in the original packaging to protect the medicine from light. During
the injection, no light protection is necessary.
After opening the infusion bag (pierced rubber stopper), the solution must be
used immediately (within three hours) to avoid any bacterial contamination.
Do not use Levofloxacina Galenica Senese infusion solution after the expiry date which is
stated on the carton.
Medicines should not be disposed of via drains or household waste. The nurse or the
pharmacist will dispose of any medicines no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Levofloxacina Galenica Senese contains
The active substance is levofloxacin. Levofloxacina Galenica Senese solution for infusion is
available in polypropylene bags of 100 ml. 1 ml of solution for infusion contains 5 mg of
levofloxacin.
The excipients are: Sodium chloride, sodium hydroxide, hydrochloric acid (q.s. to pH 4.8), water for
injections
Description of the appearance of Levofloxacina Galenica Senese solution for infusion and contents of the
pack Levofloxacina Galenica Senese solution for infusion is available in polypropylene
bags in packs of 1, 5, 10 and 20 bags.
Levofloxacina Galenica Senese is compatible with the following infusion solutions:

• sodium chloride 0.9%
• dextrose 5%
• dextrose 2.5% in Ringer's solution
• solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes) Levofloxacina Galenica Senese solution for infusion must not be mixed with heparin or with alkaline solutions (e.g. sodium bicarbonate).

Marketing authorization holder and manufacturerHolder

of the marketing authorization
Industria Farmaceutica Galenica Senese S.r.l. Via Cassia Nord 351 – 53014 Monteroni D’Arbia (SI)

Manufacturer
Industria Farmaceutica Galenica Senese S.r.l. Via Cassia Nord 351 – 53014 Monteroni D’Arbia (SI)
For further information or if you have any doubts, please ask your doctor or pharmacist.